Complaint Specialist
Core
Manage product complaints from intake through closure, evaluate reportability, and prepare regulatory reports for medical devices.
Role type
Post-market surveillance specialist (medical devices)
Builds
Regulatory compliance and patient safety reporting systems
Domain
Medical device regulation and quality management
Deliverable
client delivery
Required skills
Regulatory reporting (FDA 21 CFR 803/806, EU MDR, UK MDR, Health Canada, Japan PMD), ISO 14971 risk management, CAPA/NCR management, root cause analysis, data trending, Salesforce/EDMS proficiency
Preferred skills
Experience with software medical devices (Class II/III)
Responsibilities
Assess and document complaints across multiple channels; perform regulatory reporting determinations and prepare MDRs/vigilance reports; review complaint investigations for completeness and root cause rationale; support Quality Management System activities including audits and risk management; partner with Customer Support to clarify event details; maintain complaint handling tools and procedures.
Seniority
Junior to Mid-level, hands-on IC